US-based VentiRx Pharmaceuticals has completed the subject enrollment in GOG-3003, a Phase II study of VTX-2337 in combination with pegylated liposomal doxorubicin (PLD) in patients with recurrent or persistent epithelial ovarian, fallopian tube or primary peritoneal cancer who have failed prior platinum-based chemotherapy.
Being conducted in collaboration with the Gynecologic Oncology Group (GOG) Partners Program, GOG-3003 is one of the two Phase II clinical trials of VTX-2337 currently underway.
More than 290 patients at in excess of 85 institutions throughout North America have been randomised in the Phase II GOG-3003 study.
In this placebo-controlled study, women were randomised to receive PLD plus VTX-2337 or PLD plus placebo and the primary endpoint of the study is overall survival.
While, Active8 is the second Phase II placebo-controlled trial designed to evaluate VTX-2337 in combination with cetuximab and chemotherapy vs cetuximab and chemotherapy alone in patients with locally advanced and metastatic squamous cell carcinoma of the head and neck.
Currently, the company-sponsored, randomised Phase II study is enrolling patients in the US.
In addition to the completion of patient enrolment in the Phase II GOG-3003 study, VentiRx Pharmaceuticals has announced the designation of Orphan Drug Status by the US Food and Drug Administration to VTX-2337 for the treatment of ovarian cancer.
VTX-2337, an investigational small molecule, targets Toll-like receptor 8 (TLR8). The TLR8 agonist directly activates multiple components of the innate immune system resulting in the production of high levels of mediators known to orchestrate the integration of innate and adaptive antitumuor responses.
The TLR8 agonist activates human myeloid dendritic cells) and monocytes and natural killer cells. A recently completed Phase Ib study (GOG-9925, NCT01294293) has reported encouraging data with PLD and VTX-2337 in the treatment of platinum-resistant ovarian cancer.
VentiRx president and CEO Dr Robert Hershberg noted that completion of enrolment in the large, randomised GOG-3003 trial and receipt of orphan drug designation for VTX-2337 in ovarian cancer are important milestones for the company in the development of its novel immunomodulator VTX-2337.
"We appreciate the tremendous effort of the GOG in the enrollment of this trial ahead of schedule, and look forward to the event-driven analysis in late 2015," Dr Hershberg added.
Image: A very large ovarian cancer as seen on CT. Photo: courtesy of Jmh649.